Menu
Not yet recruiting NCT07486323

Combined Non-Invasive Brain and Visual Stimulation for Vision Improvement

No phase Interventional Glaucoma Open-Angle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NIBS, VTS, NIBS+VTS, Sham.
Who it may be relevant to
Registry conditions: Glaucoma Open-Angle. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Combined Non-invasive Brain Stimulation (NIBS) and Visual Tetanic Stimulation (VTS) for Vision Enhancement: A Randomized, Single-blind, Cross-over Trial

Overview

Glaucoma is a complex disease that can result in progressive vision loss. It is the second leading cause of blindness, accounting for 23% of permanent blindness in Hong Kong. There are no treatments that restore vision lost to glaucoma. This study will examine the effect of transcranial direct current stimulation (NIBS) on improving quality of life, visual function and functional performance in patients with peripheral field loss due to glaucoma.

Detailed description

This study uses a prospective, single-masked, randomized, cross-over, placebo-controlled training RCT design.

The eligible participants will be randomly allocated into 4 groups:

(A) Transcranial direct current stimulation; (B) Visual Tetanic Stimulation; (C) Transcranial direct current stimulation+ Visual Tetanic Stimulation; (D) Sham. All participants will underwent all the 4 types of intervention with a 14 days washing out period between intervention types:

All participants will complete twenty-six study visits:

Visit 1: Eligibility assessment (refer to the recruitment criteria); Visit 2: Outcome measures (Pre-intervention/ baseline); Visit 3-7: 5 sessions intervention (1st intervention block); Visit 8: Post 1 outcome measures; Visit 9-13: 5 sessions intervention (2nd intervention block); Visit 14: Post 2 outcome measures; Visit 15-19: 5 sessions intervention (3rd intervention block); Visit 20: Post 3 outcome measures; Visit 21-25: 5 sessions intervention (4th intervention block); Visit 26: Post 4 outcome measures

Eight sessions of assessment will be conducted: (1) Baseline-1; (2) Post-1 (after 5-sessions training); (3) Baseline-2; (4) Post-2 (after 5-sessions training); (5) Baseline-3; (6) Post-3 (after 5-sessions training); (7) Baseline-4; and (8) Post-4 (after 5-sessions training).

Interventions

  • Other NIBS
    Around 1 hour
  • Other VTS
    Around 1 hour
  • Other NIBS+VTS
    Around 1 hour
  • Other Sham
    Around 1 hour

Primary outcome measures

  • Visual field test [Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)]
  • Electroencephalography (EEG) [Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)]
  • Optical Coherence Tomography (OCT) [Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)]
  • Optical Coherence Tomography Angiography (OCT-A) [Time frame: Baseline (before the first intervention session), and immediately before and after each intervention block (5 session of intervention)]

Eligibility criteria

Inclusion criteria

  • Age range from 18 to 80 years;
  • Diagnosis of primary open angle or normal tension glaucoma with relative scotoma in both eyes;
  • A relative scotoma defined as a Humphrey Field Analyser (HFA) threshold perimetry loss (mean deviation of -6dB) within the central 24 degree of the visual field for at least one eye;
  • Best-corrected distance visual acuity of 6/12 or better (equivalent to 0.3 logMAR acuity or better to confirm that participant's central vision is preserved).
  • Stable vision and visual field loss for at least 3 months;
  • With a cognitive functional score of 22 or above in the Montreal Cognitive Assessment - Hong Kong version (HK-MoCA) (to confirm participant's intact cognitive function).

Exclusion criteria

  • Ocular diseases other than glaucoma (e.g. age-related macular degeneration, diabetic retinopathy, moderate to severe cataract) or severe hearing impairment (to ensure that participant can hear the instructions clearly during assessments and training);
  • Severe medical problems (e.g. stroke, Parkinson's disease) or self-reported neurological (e.g. brain surgery, brain tumor, peripheral neuropathy), or cognitive disorders (e.g. diagnosed dementia or cognitive impairment);
  • Self-reported vestibular or cerebellar dysfunction, history of vertigo;
  • Using any medications for any neurological conditions or psychiatric drugs (e.g. sedative, hypnotic) that might interfere motor control;
  • Contraindications for non-invasive brain stimulation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07486323 · HSEARS20251208001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗